None listed
Conditions
Interventions
Group 1 Type of group
pioglitazone 45 mg q.d. for 30 weeks
Group name:Group 2 Type of group
sitagliptin 100 mg q.d./pioglitazone 45 mg q.d. for 30 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Finish the base study in double blind. • Have a compliance> 75% with respect to the study drug during the double blind treatment period of the base study. • Understand the procedures of the extension study and agree to participate in the extension by providing written informed consent. • Potentially fertile women should continue to comply with the contraceptive methods specified in the protocol, as outlined earlier in the baseline study.
Exclusion criteria
Exclusion criteria: • The patient withdraws his informed consent or requests to be discontinued from the study. • Hyperglycemia: As of Visit 10 / Week 30, the patient has completed dose adjustment of the rescue drug metformin and has been maintained at a maximum stable dose tolerated for> 2 weeks with an FPG> 180 mg / dL ( 10 mmol / L) or the patient has an FPG or HbA1c that meets the glycemic rescue criteria (see Section 2.3.2.3) and the patient is not suitable for rescue therapy with metformin (see Section 2.3.3) . As described in Section 2.3.2.3 above, no glycemic discontinuation criteria will apply in the period after Visit 9 / Week 24 and before Visit 10 / Week 30. • Hypoglycemia: recurrence (2 or more episodes from the previous study visit) of FPG or glucose obtained by fingerstick 1.5 mg / dL (132.6 umol / L) in men and> 1.4 mg / dL (123.8 umoI / L) in women; or estimated creatinine clearance (according to the Cockcroft-Gault formula) <60 mL / min. • Requirement for one of the excluded drugs listed in Section 3.2.1. • The patient develops a condition that could contraindicate the use of pioglitazone according to the label of pioglitazone from the country of the research site in which the patient is participating. • Pregnancy. Note: A positive urine pregnancy test requires immediate discontinuation of the study drug until a serum p-hCG test can be performed and the result determined to be negative. The patient should be permanently discontinued and followed up according to Section 3.4.3 if the pregnancy is confirmed by a positive pregnancy test. • Any medical condition or personal circumstance that, in the opinion of the investigator, represents a risk to the patient if he continues in the study or does not allow him to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HbA1c Measure:The change with respect to the baseline and the change with respect to week 24 in HbA1c Timepoints:week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of FPG Measure:Change from baseline FPG in Week 54 Timepoints:Week 54 ; Outcome name:A lipid panel will be measured at the specified visits. Measure:change with respect to baseline and change with respect to Week 24 in 1.5 anhydroglucitol Timepoints:Week 24 ; Outcome name:they will be evaluated through a review of all safety parameters such as clinical adverse events, laboratory values, vital signs, body weight, and ECG information that is read locally. Measure:Safety and Tolerability Timepoints:During the study | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed